| CTRI Number |
CTRI/2025/11/098236 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two different surgery methods for Gallbladder Surgery |
|
Scientific Title of Study
|
The evaluation of robotic cholecystectomy versus laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shwetha Y |
| Designation |
Resident |
| Affiliation |
Vydehi institute of Medical Science and Research Centre |
| Address |
Vydehi institute of Medical Science and Research Centre, Whitefield,
Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
7259437307 |
| Fax |
|
| Email |
Shwetha.99121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana |
| Designation |
Professor |
| Affiliation |
Vydehi institute of Medical Science and Research Centre |
| Address |
Vydehi institute of Medical Science and Research Centre, Whitefield,
Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9632272371 |
| Fax |
|
| Email |
kalpanavineet4586@vimsmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana |
| Designation |
Professor |
| Affiliation |
Vydehi institute of Medical Science and Research Centre |
| Address |
Vydehi institute of Medical Science and Research Centre, Whitefield,
Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9632272371 |
| Fax |
|
| Email |
kalpanavineet4586@vimsmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Medical Sciences & Research Centre, Whitefield, Bengaluru, Karnataka 560066 |
|
|
Primary Sponsor
|
| Name |
Vydehi Institute of Medical Sciences & Research Centre |
| Address |
Whitefield, Bengaluru, Karnataka 560066 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shwetha Y |
Vydehi Institute of Medical Sciences & Research Centre |
Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA |
7259437307
Shwetha.99212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 18 years of age
Diagnosed with symptomatic cholelithiasis or gall bladder polyps
Eligible for minimally invasive surgery |
|
| ExclusionCriteria |
| Details |
Acute cholecystitis
History of upper abdominal surgery
Coagulopathy or uncorrected bleeding disorder
Unfit for general anaesthesia
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of surgery (in minutes) |
Day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative complications |
Day of surgery |
| Postoperative pain assessed using the Visual Analogue Scale |
6, 12, and 24 hours postoperatively |
| Length of hospital stay |
Day of Discharge |
| Cosmetic satisfaction: Measured using a 5-point Likert scale |
Day 7, Month 1, Month 2, Month 3 postoperatively |
| Postoperative complications: Including wound infection, bile leak, or any readmission |
Day 7, Month 1, Month 2, Month 3 postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cholecystectomy, performed for gallstone disease and other benign gallbladder conditions, is one of the most common abdominal surgeries worldwide. Over the past three decades, laparoscopic cholecystectomy (LC) has become the gold standard due to its minimally invasive nature, shorter recovery, and reduced postoperative complications. However, its technical limitations—such as rigid instruments and two-dimensional imaging—pose challenges in complex cases. To address these, robotic-assisted cholecystectomy (RC) has emerged, offering enhanced visualization, wristed instrumentation, and improved ergonomics, which can aid in precise dissection, particularly in difficult anatomical situations. Despite its theoretical advantages, the clinical superiority of RC over LC remains uncertain. Several studies have reported similar outcomes in terms of postoperative pain, complications, and recovery, while also noting longer operative times and higher costs associated with RC. The justification for these increased resources in standard cases is still unclear. Moreover, much of the current evidence comes from retrospective studies with small sample sizes, lacking standardization and long-term outcomes. Given the rising adoption of robotic surgery, there is a clear need for prospective comparative studies. This study aims to assess the true clinical and economic value of RC versus LC, providing evidence-based guidance for surgical practice and resource optimization. |